Adverse event reporting form
Executive Summary
FDA plans May 4 "pre-meeting" with health care professional organizations to review how the groups and FDA can work together to implement agency's upcoming common form for drugs/devices/biologics adverse events. A larger public meeting is scheduled for June 3 ("The Pink Sheet" April 9, In Brief). FDA requests that only one representative of each organization attend the May 4 session and register via fax (301/443-2446) to agency's Office of Health Affairs.